Analyst II, QC Cell and Molecular Biology

Allogene Therapeutics
San Francisco, California, US
Jul 21, 2021
Jul 30, 2021
Employment Type
Full time
Salary Type
Analyst II, QC Cell and Molecular Biology Quality | South San Francisco, CA | Full Time

Job Description

About Allogene Therapeutics, Inc:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR Tâ„¢) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and follow @AllogeneTx on Twitter and LinkedIn.

Job Description:

Allogene is seeking an analyst II to support routine testing and logistical activities in the QC Cell and Molecular Biology (CMB) laboratory. This incumbent will execute core laboratory testing from PCR, flow cytometry, ELISA, cell culture/counting, and other related testing and compendial test methods (pH, Volume, appearance, Osmolality). The incumbent will support logistical activities in the lab including sample receipt and will support GMP QC laboratory maintenance by managing and/or monitoring facilities, and laboratory equipment and reagents. The incumbent will perform all activities in a GMP environment by accurately following procedures, maintaining accurate and contemporaneous documentation, monitoring methods performance and reporting any deviation or discrepancy to manager. The incumbent's duties are primarily internal, and the analyst is expected to interact with peers and management within QC and QA. Initially the role will be based in our South San Francisco office, but will move to the Newark manufacturing site in the next year.

Responsibilities include, but are not limited to:
  • Performs QC analytical testing to support the release and stability of final products to support the release of products for commercial use, with consideration of compliance, quality, and consistency.
  • Review test methods data and supporting documentation.
  • Maintains GMP laboratories by monitoring lab equipment, pipettes, etc. and availability of lab supply. Perform instrument/equipment cleaning per the schedule and support calibration as needed.
  • Support minor equipment troubleshooting, laboratory maintenance and cleaning activities.
  • Manages GMP and non-GMP samples, order and receive lab reagents and materials, and manages the inventories. Support ordering and qualification of critical reagents as requested.
  • Accurately follows relevant SOPs, performs all activities in accordance with cGMP requirements reports abnormalities.
  • Documents test results to ensure completeness and accuracy per cGMP. Keeps accurate documentation and tracks record.
  • Support troubleshooting with minor assay performance issue and support the SOP related activities as requested.
  • Supports Discrepancy Management investigations and implementation of corrective and preventative actions as instructed.
  • Contributes toward the development and revision of SOPs and Test Methods.
  • Support method optimization, validation and transfer of QC CMB methods and critical reagent qualification by executing as instructed.
  • Perform non-routine laboratory tasks.

Position Requirements & Experience:
  • A minimum B.S. degree in a scientific discipline with minimum 3 years of experiences in a cGMP compliant environment or equivalent combination of education and experience
  • Demonstrated knowledge in most of "core" laboratory techniques (e.g. ELISA, Cell culture and Cell-based assay, PCR, Flow cytometry, etc.)
  • Must have some previous working experience in aseptic technique
  • Should have extensive experience in Cell-based assay, qPCR assay, flow cytometry or Immunoassay
  • Experience in maintenance of GMP laboratory, laboratory equipment, and the status of pipettes and supplies. - Able to perform QC laboratory maintenance related duties as assigned
  • Able to follow instructions and SOPs precisely and able to make/keep accurate and contemporaneous documentation
  • Experience of supporting analytical method validation and transfer, reagent qualification, or the method maintenance
  • Report an issue in the assay performance and support troubleshoot and optimization of the method to improve the performance
  • Able to support Invalid, OOE, and OOS investigation or CAPA initiation
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
  • Maintain good interaction with subordinates, peers and leadership within Quality Control
  • Able to learn new skills rapidly and achieve proficiency
  • Able to seek and accept input from more senior team members for the performance of assignments as needed
  • Ability to work independently and as part of a team
  • Physically able to lift LN2 freezer rack or move up to 20L buffer if needed as laboratory activities
  • Candidates must be authorized to work in the U.S

As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.